Final Combo Product GMP Requirements Are More Of The Same; Encourage FDA Meetings

The Food and Drug Administration’s Federal Register Notice [LINK] for a streamlined approach to combination product good manufacturing processes (GMPs) doesn’t change any of the agency’s expectations for manufacturers.

The 13 September notice completes a task set out by 2016’s 21st Century Cures Act, MEDIcept Inc. managing director Kim Trautman explained in an email to Medtech Insight on 14...